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    Chemistry

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    Also known as: 104227-87-4, Famvir, Brl-42810, Famciclovirum, 2-(2-(2-amino-9h-purin-9-yl)ethyl)propane-1,3-diyl diacetate, Famciclovirum [inn-latin]
    Molecular Formula
    C14H19N5O4
    Molecular Weight
    321.33  g/mol
    InChI Key
    GGXKWVWZWMLJEH-UHFFFAOYSA-N
    FDA UNII
    QIC03ANI02
    Famciclovir
    An aminopurine derivative and prodrug of penciclovir which is a competitive inhibitor of herpes simplex 2 DNA polymerase. It is used to treat HERPES SIMPLEX VIRUS INFECTION.
    Famciclovir is a Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor. The mechanism of action of famciclovir is as a DNA Polymerase Inhibitor, and DNA Polymerase Inhibitor.
    1 2D Structure

    Famciclovir

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [2-(acetyloxymethyl)-4-(2-aminopurin-9-yl)butyl] acetate
    2.1.2 InChI
    InChI=1S/C14H19N5O4/c1-9(20)22-6-11(7-23-10(2)21)3-4-19-8-17-12-5-16-14(15)18-13(12)19/h5,8,11H,3-4,6-7H2,1-2H3,(H2,15,16,18)
    2.1.3 InChI Key
    GGXKWVWZWMLJEH-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(=O)OCC(CCN1C=NC2=CN=C(N=C21)N)COC(=O)C
    2.2 Other Identifiers
    2.2.1 UNII
    QIC03ANI02
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1,3-propanediol, 2-(2-(2-amino-9h-purin-9-yl)ethyl)-, Diacetate (ester)

    2. 9-(4-acetoxy-3-(acetoxymethyl)but-1-yl)-2-aminopurine

    3. Brl 42810

    4. Brl-42810

    5. Brl42810

    6. Famvir

    2.3.2 Depositor-Supplied Synonyms

    1. 104227-87-4

    2. Famvir

    3. Brl-42810

    4. Famciclovirum

    5. 2-(2-(2-amino-9h-purin-9-yl)ethyl)propane-1,3-diyl Diacetate

    6. Famciclovirum [inn-latin]

    7. Brl 42810

    8. [2-(acetyloxymethyl)-4-(2-aminopurin-9-yl)butyl] Acetate

    9. Famciclovir (famvir)

    10. 2-[(acetyloxy)methyl]-4-(2-amino-9h-purin-9-yl)butyl Acetate

    11. Fcv

    12. Chebi:4974

    13. 9-[4-acetoxy-3-(acetoxymethyl)but-1-yl]-2-aminopurine

    14. Nsc-758921

    15. Qic03ani02

    16. 1,3-propanediol, 2-(2-(2-amino-9h-purin-9-yl)ethyl)-, Diacetate (ester)

    17. 2-(2-(2-amino-9h-purin-9-yl)ethyl)-1,3-propanediol Diacetate (ester)

    18. Ncgc00095133-01

    19. Famciclovir 100 Microg/ml In Acetonitrile

    20. 2-(2-(2-amino-9h-purin-9-yl)ethyl)-1,3-propanediol Diacetate

    21. 2-[2-(2-amino-9h-purin-9-yl)ethyl]-1,3-propanediol Diacetate

    22. Dsstox_cid_3038

    23. Dsstox_rid_76845

    24. Dsstox_gsid_23038

    25. Oravir

    26. Acetic Acid 2-acetoxymethyl-4-(2-amino-purin-9-yl)-butyl Ester

    27. 2-(acetoxymethyl)-4-(2-amino-4,5-dihydro-9h-purin-9-yl)butyl Acetate

    28. 2-[2-(2-amino-9h-purin-9-yl)ethyl]trimethylene Diacetate;2-[2-(2-amino-9h-purin-9-yl)ethyl]trimethylene Diacetate

    29. Smr000466375

    30. Famvir (tn)

    31. Cas-104227-87-4

    32. Sr-01000759358

    33. Unii-qic03ani02

    34. Famciclovir [usan:inn:ban]

    35. 1,3-propanediol, 2-[2-(2-amino-9h-purin-9-yl)ethyl]-, Diacetate (ester)

    36. 2-[2-(2-amino-9h-purin-9-yl)ethyl]-1,3-propanediol Diacetate (ester)

    37. Hsdb 8121

    38. Famciclovir,(s)

    39. Brl42810

    40. Famciclovir, Bio-x

    41. Mfcd00866964

    42. 1,3-diyl Diacetate

    43. Spectrum_000466

    44. Famciclovir [mi]

    45. Spectrum2_001101

    46. Spectrum3_001675

    47. Spectrum4_000611

    48. Spectrum5_001548

    49. Famciclovir [inn]

    50. Famciclovir [jan]

    51. Famciclovir [usan]

    52. Chembl880

    53. Famciclovir [vandf]

    54. Schembl2949

    55. Famciclovir [mart.]

    56. Bspbio_003489

    57. Famciclovir [usp-rs]

    58. Famciclovir [who-dd]

    59. Kbiogr_001162

    60. Kbioss_000946

    61. Mls000759505

    62. Mls001424115

    63. Mls006011896

    64. Famciclovir (jan/usp/inn)

    65. Spectrum1505201

    66. Spbio_001202

    67. Dtxsid0023038

    68. Famciclovir, >=98% (hplc)

    69. Gtpl11629

    70. Kbio2_000946

    71. Kbio2_003514

    72. Kbio2_006082

    73. Kbio3_002709

    74. [2-(acetoxymethyl)-4-(2-aminopurin-9-yl)butyl] Acetate

    75. Famciclovir [orange Book]

    76. Hms1922l09

    77. Hms2051g22

    78. Hms2090g10

    79. Hms2093k12

    80. Hms2232h09

    81. Hms3262o08

    82. Hms3370d14

    83. Hms3393g22

    84. Hms3656a04

    85. Hms3715f03

    86. Pharmakon1600-01505201

    87. Famciclovir [usp Monograph]

    88. Albb-027262

    89. Bcp21312

    90. Diacetyl 6-deoxy-9-(4-hydroxy-3-hydroxymethyl-but-1-yl)guanine

    91. Zinc1530635

    92. Tox21_111442

    93. Tox21_500793

    94. Ak-120

    95. Bdbm50248001

    96. Ccg-39277

    97. Nsc758921

    98. S2467

    99. Stk623204

    100. 2-(2-(2-amino-9h-purin-9-yl)ethyl)-1,3-propanediol Diacetate Ester

    101. Akos005556609

    102. Tox21_111442_1

    103. Ab07547

    104. Ac-8066

    105. Cs-1357

    106. Db00426

    107. Ks-5020

    108. Nc00156

    109. Nsc 758921

    110. Ncgc00095133-02

    111. Ncgc00095133-03

    112. Ncgc00095133-04

    113. Ncgc00095133-06

    114. Ncgc00095133-15

    115. Ncgc00261478-01

    116. Bf164441

    117. Hy-17426

    118. Sbi-0206743.p001

    119. Db-014809

    120. F0842

    121. Ft-0602549

    122. Ft-0668461

    123. Sw197536-3

    124. A19583

    125. D00317

    126. 2-(2-(2-amino-9h-purin-9-yl)ethyl)propane-

    127. Ab00639952-06

    128. Ab00639952-08

    129. Ab00639952_09

    130. Ab00639952_10

    131. 227f874

    132. Q420186

    133. Brl-42810;brl42810;brl 42810;famciclovirum

    134. J-001134

    135. Sr-01000759358-4

    136. Sr-01000759358-5

    137. 9-(4-acetoxy-3-acetoxymethylbut-1-yl)-2-aminopurine

    138. Brd-k45033733-001-02-3

    139. Brd-k45033733-001-05-6

    140. 9-[4-acetoxy-3-(acetoxymethyl)butyl]-2-amino-9h Purine

    141. [2-(acetyloxymethyl)-4-(2-aminopurin-9-yl)-butyl] Acetate

    142. 2-(2-(2-amino-9h-purin-9-yl)ethyl)-propane-1,3-diyl Diacetate

    143. Famciclovir, United States Pharmacopeia (usp) Reference Standard

    144. Famciclovir, Pharmaceutical Secondary Standard; Certified Reference Material

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 321.33 g/mol
    Molecular Formula C14H19N5O4
    XLogP30
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count9
    Exact Mass321.14370410 g/mol
    Monoisotopic Mass321.14370410 g/mol
    Topological Polar Surface Area122 Ų
    Heavy Atom Count23
    Formal Charge0
    Complexity404
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameFamciclovir
    PubMed HealthFamciclovir (By mouth)
    Drug ClassesAntiviral
    Drug LabelFamciclovir tablets contains famciclovir, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. It is a synthetic acyclic guanine derivativ...
    Active IngredientFamciclovir
    Dosage FormTablet
    RouteOral
    Strength250mg; 125mg; 500mg
    Market StatusPrescription
    CompanyHetero Labs Ltd V; Teva Pharms; Macleods Pharms; Apotex; Aurobindo Pharma; Cipla; Mylan; Roxane

    2 of 4  
    Drug NameFamvir
    PubMed HealthFamciclovir (By mouth)
    Drug ClassesAntiviral
    Drug LabelThe active ingredient in FAMVIR tablets is famciclovir, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C14H...
    Active IngredientFamciclovir
    Dosage FormTablet
    RouteOral
    Strength250mg; 125mg; 500mg
    Market StatusPrescription
    CompanyNovartis

    3 of 4  
    Drug NameFamciclovir
    PubMed HealthFamciclovir (By mouth)
    Drug ClassesAntiviral
    Drug LabelFamciclovir tablets contains famciclovir, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. It is a synthetic acyclic guanine derivativ...
    Active IngredientFamciclovir
    Dosage FormTablet
    RouteOral
    Strength250mg; 125mg; 500mg
    Market StatusPrescription
    CompanyHetero Labs Ltd V; Teva Pharms; Macleods Pharms; Apotex; Aurobindo Pharma; Cipla; Mylan; Roxane

    4 of 4  
    Drug NameFamvir
    PubMed HealthFamciclovir (By mouth)
    Drug ClassesAntiviral
    Drug LabelThe active ingredient in FAMVIR tablets is famciclovir, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C14H...
    Active IngredientFamciclovir
    Dosage FormTablet
    RouteOral
    Strength250mg; 125mg; 500mg
    Market StatusPrescription
    CompanyNovartis

    4.2 Therapeutic Uses

    Antiviral Agents

    National Library of Medicine's Medical Subject Headings online file (MeSH, 2013)

    Oral famciclovir is used for the treatment of acute, localized herpes zoster (shingles, zoster). /Included in US product label/

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 812

    Oral famciclovir is used for the treatment of recurrent mucocutaneous herpes simplex virus (HSV) infections (HSV-1 and HSV-2) in HIV-infected adults. /Included in US product label/

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 813

    Famciclovir has been used for the management of chronic hepatitis B virus (HBV) infection in a limited number of patients. /NOT included in US product label/

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 813

    For more Therapeutic Uses (Complete) data for Famciclovir (12 total), please visit the HSDB record page.

    4.3 Drug Warning

    /These/ adverse events have been reported during post-approval use of Famvir. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders: Thrombocytopenia. Hepatobiliary disorders: Abnormal liver function tests, cholestatic jaundice. Nervous system disorders: Dizziness, somnolence. Psychiatric disorders: Confusion (including delirium, disorientation, and confusional state occurring predominantly in the elderly), hallucinations. Skin and subcutaneous tissue disorders: Urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema (e.g. face, eyelid, periorbital, and pharyngeal edema).

    US Natl Inst Health; DailyMed. Current Medication Information for FAMVIR (famciclovir) tablet, film coated (February 2012). Available from, as of March 16, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3c6194c0-ba69-4b16-b882-caf736a02348

    The manufacturer recommends that the dosage interval of famciclovir be adjusted carefully in patients with impaired renal function to prevent drug accumulation while maintaining adequate plasma concentrations of penciclovir, the active metabolite of famciclovir.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 815

    Increased serum concentrations of ALT (SGPT) occurred in 1.4-2.4% of patients receiving famciclovir in clinical trials for herpes zoster or genital herpes. Increased serum concentrations of alkaline phosphatase, total bilirubin, and albumin each occurred rarely in patients receiving the drug in clinical trials for herpes zoster or genital herpes.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 814

    The most frequent adverse GI effect of famciclovir is nausea which occurred in approximately 13% of patients receiving the drug (versus in 11.6% in placebo recipients) in a large, controlled clinical trial for herpes zoster. Nausea resulted in discontinuance of famciclovir in less than 1% of patients in clinical trials for herpes zoster or genital herpes. Diarrhea was reported in approximately 8% of patients (5% of placebo recipients) and vomiting in approximately 5% of patients (3.4% of placebo recipients) in a large, controlled clinical trial for herpes zoster. Vomiting only rarely resulted in discontinuance of famciclovir in clinical trials for herpes zoster or genital herpes. Constipation, anorexia, abdominal pain, flatulence, and dyspepsia have occurred in patients receiving famciclovir in clinical trials for herpes zoster. Acute necroticohemorrhagic pancreatitis resulting in death has been reported following famciclovir administration for severe hepatitis B virus infection in a kidney graft recipient who was receiving cyclosporine concomitantly; a causal relationship to famciclovir was not established. Nausea, diarrhea, vomiting, or abdominal pain has been reported in 11, 7, 5, or 3%, respectively, of HIV-infected patients receiving famciclovir in clinical studies.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 814

    For more Drug Warnings (Complete) data for Famciclovir (12 total), please visit the HSDB record page.

    4.4 Drug Indication

    For the treatment of acute herpes zoster (shingles). Also for the treatment or suppression of recurrent genital herpes in immunocompetent patients and treatment of recurrent mucocutaneous herpes simplex infections in HIV infected patients.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Famciclovir is a prodrug that undergoes rapid biotransformation to the active antiviral compound penciclovir. Penciclovir is an anti-viral drug which has inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella zoster virus (VZV). Therefore, herpes viral DNA synthesis and replication are selectively inhibited.

    5.2 MeSH Pharmacological Classification

    Nucleic Acid Synthesis Inhibitors

    Compounds that inhibit cell production of DNA or RNA. (See all compounds classified as Nucleic Acid Synthesis Inhibitors.)

    Antiviral Agents

    Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. (See all compounds classified as Antiviral Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    FAMCICLOVIR
    5.3.2 FDA UNII
    QIC03ANI02
    5.3.3 Pharmacological Classes
    Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]; Nucleoside Analog [EXT]; DNA Polymerase Inhibitors [MoA]
    5.4 ATC Code

    J - Antiinfectives for systemic use

    J05 - Antivirals for systemic use

    J05A - Direct acting antivirals

    J05AB - Nucleosides and nucleotides excl. reverse transcriptase inhibitors

    J05AB09 - Famciclovir

    S - Sensory organs

    S01 - Ophthalmologicals

    S01A - Antiinfectives

    S01AD - Antivirals

    S01AD07 - Famciclovir

    5.5 Absorption, Distribution and Excretion

    Absorption

    77 %

    Route of Elimination

    Active tubular secretion contributes to the renal elimination of penciclovir.

    Volume of Distribution

    1.080.17 L/kg [healthy male subjects following a single intravenous dose of penciclovir at 400 mg administered as a 1-hour intravenous infusion]

    Clearance

    36.6 +/- 6.3 L/hr [healthy male]

    0.48 +/- 0.09 L/hr/kg [healthy male]

    Following oral administration of famciclovir to lactating rats, penciclovir was distributed into breast milk at concentrations higher than those observed in plasma.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 815

    Not known whether penciclovir crosses the placenta or is distributed into human milk.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 815

    Following oral single-dose administration of 500 mg famciclovir to seven patients with herpes zoster, the AUC (mean + or - SD), Cmax, and tmax were 12.1+ or - 1.7 ug hr/mL, 4.0 + or - 0.7 ug/mL, and 0.7 + or - 0.2 hours, respectively. The AUC of penciclovir was approximately 35% greater in patients with herpes zoster as compared to healthy volunteers. Some of this difference may be due to differences in renal function between the two groups.

    US Natl Inst Health; DailyMed. Current Medication Information for FAMVIR (famciclovir) tablet, film coated (February 2012). Available from, as of March 16, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3c6194c0-ba69-4b16-b882-caf736a02348

    Renal clearance of penciclovir following the oral administration of a single 500 mg dose of famciclovir to 109 healthy male volunteers was 27.7+ or - 7.6 L/hr. Active tubular secretion contributes to the renal elimination of penciclovir.

    US Natl Inst Health; DailyMed. Current Medication Information for FAMVIR (famciclovir) tablet, film coated (February 2012). Available from, as of March 16, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3c6194c0-ba69-4b16-b882-caf736a02348

    For more Absorption, Distribution and Excretion (Complete) data for Famciclovir (11 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Hepatic

    Famciclovir is deacetylated and oxidized to penciclovir. Penciclovir is phosphorylated to penciclovir triphosphate (the active metabolite) in cells infected with HSV-1, HSV-2, or VZV. The inactive metabolite 6-deoxy penciclovir is converted to penciclovir by aldehyde oxidase. Famciclovir not metabolized by CYP enzymes.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 815

    Following oral administration, famciclovir is deacetylated and oxidized to form penciclovir. Metabolites that are inactive include 6-deoxy penciclovir, monoacetylated penciclovir, and 6-deoxy monoacetylated penciclovir (5%, <0.5% and <0.5% of the dose in the urine, respectively). Little or no famciclovir is detected in plasma or urine. An in vitro study using human liver microsomes demonstrated that cytochrome P450 does not play an important role in famciclovir metabolism. The conversion of 6-deoxy penciclovir to penciclovir is catalyzed by aldehyde oxidase.

    US Natl Inst Health; DailyMed. Current Medication Information for FAMVIR (famciclovir) tablet, film coated (February 2012). Available from, as of March 16, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3c6194c0-ba69-4b16-b882-caf736a02348

    5.7 Biological Half-Life

    10 hours

    Elimination half-life of penciclovir after oral administration of famciclovir 1.6-3 hours. Intracellular half-life of penciclovir triphosphate in cells infected with herpes simplex virus (HSV)-1 or HSV-2 is 10 and 20 hours, respectively; intracellular half-life in varicella zoster virus (VZV)-infected cells is 7-14 hours.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 815

    The plasma elimination half-life of penciclovir was 2.0 + or - 0.3 hours after intravenous administration of penciclovir to 48 healthy male volunteers and 2.3 + or - 0.4 hours after oral administration of 500 mg famciclovir to 124 healthy male volunteers. The half-life in 17 patients with herpes zoster was 2.8 + or - 1.0 hours and 2.7 + or - 1.0 hours after single and repeated doses, respectively.

    US Natl Inst Health; DailyMed. Current Medication Information for FAMVIR (famciclovir) tablet, film coated (February 2012). Available from, as of March 16, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3c6194c0-ba69-4b16-b882-caf736a02348

    5.8 Mechanism of Action

    Famciclovir undergoes rapid biotransformation to the active antiviral compound penciclovir, which has inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella zoster virus (VZV). In cells infected with HSV-1, HSV-2 or VZV, viral thymidine kinase phosphorylates penciclovir to a monophosphate form that, in turn, is converted to penciclovir triphosphate by cellular kinases. In vitro studies demonstrate that penciclovir triphosphate inhibits HSV-2 DNA polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited.

    Famciclovir is a prodrug of penciclovir, which has demonstrated inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella zoster virus (VZV). In cells infected with HSV-1, HSV-2 or VZV, the viral thymidine kinase phosphorylates penciclovir to a monophosphate form that, in turn, is converted by cellular kinases to the active form penciclovir triphosphate. Biochemical studies demonstrate that penciclovir triphosphate inhibits HSV-2 DNA polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited. Penciclovir triphosphate has an intracellular half-life of 10 hours in HSV-1-, 20 hours in HSV-2- and 7 hours in VZV-infected cells grown in culture. However, the clinical significance of the intracellular half-life is unknown.

    US Natl Inst Health; DailyMed. Current Medication Information for FAMVIR (famciclovir) tablet, film coated (February 2012). Available from, as of March 16, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3c6194c0-ba69-4b16-b882-caf736a02348

    API Reference Price

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    28-Jan-2021
    26-Nov-2024
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 125MG **Federal Regist...DOSAGE - TABLET;ORAL - 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20363

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    DOSAGE - TABLET;ORAL - 250MG **Federal Regist...DOSAGE - TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20363

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    DOSAGE - TABLET;ORAL - 500MG **Federal Regist...DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20363

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    USP

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    ABOUT THIS PAGE

    Famciclovir Manufacturers

    A Famciclovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Famciclovir, including repackagers and relabelers. The FDA regulates Famciclovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Famciclovir API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Famciclovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Famciclovir Suppliers

    A Famciclovir supplier is an individual or a company that provides Famciclovir active pharmaceutical ingredient (API) or Famciclovir finished formulations upon request. The Famciclovir suppliers may include Famciclovir API manufacturers, exporters, distributors and traders.

    click here to find a list of Famciclovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Famciclovir USDMF

    A Famciclovir DMF (Drug Master File) is a document detailing the whole manufacturing process of Famciclovir active pharmaceutical ingredient (API) in detail. Different forms of Famciclovir DMFs exist exist since differing nations have different regulations, such as Famciclovir USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Famciclovir DMF submitted to regulatory agencies in the US is known as a USDMF. Famciclovir USDMF includes data on Famciclovir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Famciclovir USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Famciclovir suppliers with USDMF on PharmaCompass.

    Famciclovir JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Famciclovir Drug Master File in Japan (Famciclovir JDMF) empowers Famciclovir API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Famciclovir JDMF during the approval evaluation for pharmaceutical products. At the time of Famciclovir JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Famciclovir suppliers with JDMF on PharmaCompass.

    Famciclovir KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Famciclovir Drug Master File in Korea (Famciclovir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Famciclovir. The MFDS reviews the Famciclovir KDMF as part of the drug registration process and uses the information provided in the Famciclovir KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Famciclovir KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Famciclovir API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Famciclovir suppliers with KDMF on PharmaCompass.

    Famciclovir WC

    A Famciclovir written confirmation (Famciclovir WC) is an official document issued by a regulatory agency to a Famciclovir manufacturer, verifying that the manufacturing facility of a Famciclovir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Famciclovir APIs or Famciclovir finished pharmaceutical products to another nation, regulatory agencies frequently require a Famciclovir WC (written confirmation) as part of the regulatory process.

    click here to find a list of Famciclovir suppliers with Written Confirmation (WC) on PharmaCompass.

    Famciclovir NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Famciclovir as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Famciclovir API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Famciclovir as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Famciclovir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Famciclovir NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Famciclovir suppliers with NDC on PharmaCompass.

    Famciclovir GMP

    Famciclovir Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Famciclovir GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Famciclovir GMP manufacturer or Famciclovir GMP API supplier for your needs.

    Famciclovir CoA

    A Famciclovir CoA (Certificate of Analysis) is a formal document that attests to Famciclovir's compliance with Famciclovir specifications and serves as a tool for batch-level quality control.

    Famciclovir CoA mostly includes findings from lab analyses of a specific batch. For each Famciclovir CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Famciclovir may be tested according to a variety of international standards, such as European Pharmacopoeia (Famciclovir EP), Famciclovir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Famciclovir USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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